Presently, vaginal specula are used in the diagnostic medical field to examine the cervix of a female patient. A number of various specula designs have been developed, including disposable plastic versions that are designed for single use or single patient use. Applicant has previously developed a line of disposable plastic vaginal specula that are defined by an upper blade and a lower blade, the latter including a pistol-grip like handle portion having a receiving cavity that is sized to retain an illumination assembly. The handle portion further includes a curved light pipe disposed in the upper end of the handle portion and along the lower blade wherein light from the illumination assembly is directed towards the target. The illumination assembly includes a housing containing a miniature light source, such as a miniature incandescent lamp, which is tethered by means of a cable to a power source, such as a wall transformer. The user grips the handle portion having the inserted illumination assembly and views the cervix after the blades have been opened in the patient through articulation of the blades. The cervix is viewed through an aperture formed in the proximal end of the speculum. The speculum is discarded after use, but the illumination assembly is reusable between patients.
A number of problems have been discovered in the use and maintenance of such apparatus. For example, the use of a tethered illumination assembly that requires an AC or similar power source is often inconvenient in the field, particularly remote areas in which access to such a power supply is uncertain. In addition, the use of a tethered illumination assembly presents access and other issues, for example, with bed-ridden patients. There are similar concerns relating to the use of incandescent lamps as a light source in that such sources are typically sealed within the housing of the illumination assembly and are subject to breakage, for example, if the illumination assembly is dropped. Incandescent lamps produce significant heat, which is a concern to both the caregiver and the patient, and have a finite service life, requiring periodic teardown or replacement of the entire illumination assembly. In addition, incandescent lamps are relatively expensive, as compared, for example, with other types of commercially available light sources, thereby impacting the cost of such apparatus.
In the utilization of alternative light sources, one concern that becomes more important is insuring that adequate alignment is realized between the light source and the curved light pipe. Lack of sufficient optical coupling between these components would result in inadequate or inconsistent illumination and light spot quality.
Another encountered problem relates to cleaning of illumination assemblies between patient examinations. The nature of a cervical examination includes the presence of bodily fluids, requiring the caregiver to wear gloves in handling the apparatus to avoid cross contamination. Though the speculum is a disposable component, there is a need to clean the reusable illuminator between patient examinations. In addition, there is a further tendency for the user to pinch or snag his or her glove or fingers during operation using the above apparatus, either in fitting the illumination assembly within the speculum or otherwise.
It is therefore a desired need to improve the state of the art of illuminators that are used in vaginal speculum assemblies and also to minimize at least some of the above stated problems confronted by the patient and caregiver in the use and operation of same.